0
1The Future of Anti-InfectivesESTABLISH 2 Top Line Data ReleaseMarch 25, 2013
2Forward Looking StatementsStatements contained in this data release regarding matters that are nothistorical facts are “f...
3ESTABLISH 2 (IV/PO) Phase 3 Trial Design2oEMA1oEMATedizolidLinezolid1x 200mg2x 600mgn=6661oFDA2oFDAPlaceboPost-Treatment ...
4ESTABLISH 2 Primary & Secondary EndpointsPrimary Endpoint:• 20% or greater reduction in lesion area at 48-72 hours after ...
5ESTABLISH 2 Demographics and Baseline CharacteristicsTedizolid, %n = 332Linezolid, %n = 334Male, % 67.8 64.1Age, mean 45....
6ESTABLISH 2 EfficacyITT Analysis Set EndpointTedizolid6 daystreatment, %n = 332Linezolid10 daystreatment, %n = 334Treatme...
7ESTABLISH 2 Efficacy by Infection TypeITT Analysis SetTedizolid6 daystreatment, %n = 332Linezolid10 daystreatment, %n = 3...
8ESTABLISH 2 Safety: Tedizolid was Safe and WellTolerated with a Favorable AE Profile vs LinezolidSafety Analysis SetTediz...
9ESTABLISH 2 Incidence of TEAEs >2%System Organ ClassTedizolid, (%)n = 331Linezolid, (%)n =327Gastrointestinal disorders 5...
10ESTABLISH 2 Post-Baseline Substantially AbnormalHematology ValuesTedizolid, (%)n = 331Linezolid, (%)n =327Hemoglobin 292...
11Differences Between ESTABLISH 1 and 2ESTABLISH 2 ESTABLISH 1DosingIV to oral(minimum 1st day’s dosing IV)OralDemographic...
12ESTABLISH Program ComparisonEndpoint StudyTedizolid6 daystreatment, %Linezolid10 daystreatment, %TreatmentDifference(95%...
13ESTABLISH Program Safety ComparisonSafety Analysis Set Study Tedizolid % Linezolid %Any TreatmentEmergent AdverseEvent (...
14Summary• All primary and secondary efficacy endpoints were met for FDA and EMA• Safety profile indicated that tedizolid ...
15*Efficacy performance ratings among those aware of brandTedizolid ATU Study, Wave 1 – USA Report, conducted by CMI on be...
16Strong Response to Tedizolid Safety & TolerabilityKeyDriversofMarketShareTedizolid, 48%Tedizolid, 53%Tedizolid, 59%Zyvox...
1780%69% 74% 72% 76%92%83%19%31% 25% 27% 23%7%17%High Interest (8-10)Neutral (4-7)Low Interest (1-3)Tedizolid ATU Study, W...
18Upcoming Milestones• Late breaker presentations at ECCMID conference (submitted for April)• Detailed data presentations ...
Upcoming SlideShare
Loading in...5
×

Trius mar13presentation

138

Published on

Published in: Business, Health & Medicine
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
138
On Slideshare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
5
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Transcript of "Trius mar13presentation"

  1. 1. 1The Future of Anti-InfectivesESTABLISH 2 Top Line Data ReleaseMarch 25, 2013
  2. 2. 2Forward Looking StatementsStatements contained in this data release regarding matters that are nothistorical facts are “forward-looking statements” within the meaning ofthe Private Securities Litigation Reform Act of 1995. Because suchstatements are subject to risks and uncertainties, actual results maydiffer materially from those expressed or implied by such forward-lookingstatements. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Trius’ estimates regardingexpenses, future revenues and capital requirements; the success andtiming of Trius’ preclinical studies and clinical trials; regulatorydevelopments in the United States and foreign countries; changes inTrius’ plans to develop and commercialize its product candidates; Trius’ability to obtain additional financing; Trius’ ability to obtain and maintainintellectual property protection for its product candidates; and the loss ofkey scientific or management personnel. These and other risks anduncertainties are described more fully in Trius’ most recently filed SECdocuments, including its Form 10-K, Forms 10-Q and other documentsfiled with the United States Securities and Exchange Commission,including those factors discussed under the caption “Risk Factors” insuch filings. All forward-looking statements contained in this pressrelease speak only as of the date on which they were made. Triusundertakes no obligation to update such statements to reflect events thatoccur or circumstances that exist after the date on which they weremade.
  3. 3. 3ESTABLISH 2 (IV/PO) Phase 3 Trial Design2oEMA1oEMATedizolidLinezolid1x 200mg2x 600mgn=6661oFDA2oFDAPlaceboPost-Treatment EvaluationsEND-POINTS FOR GLOBAL REGISTRATIONSafety AnalysisNon-inferiority trial design vs Linezolid
  4. 4. 4ESTABLISH 2 Primary & Secondary EndpointsPrimary Endpoint:• 20% or greater reduction in lesion area at 48-72 hours after first dose of drugSecondary Endpoints:• Programmatic clinical response at end of therapy (EOT)• Investigator’s assessment of clinical response at post treatment evaluation (PTE)
  5. 5. 5ESTABLISH 2 Demographics and Baseline CharacteristicsTedizolid, %n = 332Linezolid, %n = 334Male, % 67.8 64.1Age, mean 45.6 45.6Geographic Region, %North America (US) 47.0 47.3Ex-U.S. 53.0 52.7Clinical Syndrome, %Cellulitis/erysipelas 50.0 50.3Major abscess 20.5 20.4Wound infection 29.5 29.3MRSA (MITT), % 27.2 26.9MSSA (MITT), % 52.8 53.0Lymphadenopathy, % 70.8 70.4WBC < 4,000 or > 10,000, % 53.0 45.2Immature neutrophils, % 16.2 12.2Fever, % 31.0 29.0
  6. 6. 6ESTABLISH 2 EfficacyITT Analysis Set EndpointTedizolid6 daystreatment, %n = 332Linezolid10 daystreatment, %n = 334TreatmentDifference(95% CI), %Primary Endpoint≥20% decrease frombaseline in lesionarea at 48-72 hours85.2 82.6 2.6 (-3.0 to 8.2)Key SecondaryEndpointsSustained clinicalresponse at end oftherapy87.0 88.0 -1.0 (-6.1 to 4.1)Investigatorsassessment ofclinical response at7-14 days after endof therapy88.0 87.7 0.3 (-4.8 to 5.3)Sensitivityanalysis(2010 Guidance)Cessation of lesionspread and absenceof fever at 48-72 hrs85.8 81.4 4.4 (-1.2 to 10.1)
  7. 7. 7ESTABLISH 2 Efficacy by Infection TypeITT Analysis SetTedizolid6 daystreatment, %n = 332Linezolid10 daystreatment, %n = 334TreatmentDifference(95% CI), %Cellulitis/erysipelas80.7n = 16680.4n = 1680.37 (-8.2 to 8.9)Major cutaneousabscess86.8n = 6889.7n = 68-2.9 (-14.5 to 8.4)Wound infection91.8n = 9881.6n = 9810.2 (0.71 to 20.1)
  8. 8. 8ESTABLISH 2 Safety: Tedizolid was Safe and WellTolerated with a Favorable AE Profile vs LinezolidSafety Analysis SetTedizolid6 days treatment, %Linezolid10 days treatment, %Any Treatment EmergentAdverse Event (TEAE)45.3 43.7Any Drug Related TEAE 20.5 24.8Gastrointestinal Disorders 16.0 20.5No Safety Signals
  9. 9. 9ESTABLISH 2 Incidence of TEAEs >2%System Organ ClassTedizolid, (%)n = 331Linezolid, (%)n =327Gastrointestinal disorders 53 (16.0) 67 (20.5)General disorders andadministration site conditions23 (6.9) 24 (7.3)Infections and infestations 40 (12.1) 40 (12.2)Metabolism and nutritiondisorders9 (2.7) 7 (2.1)Musculoskeletal and connectivetissue disorders9 (2.7) 9 (2.8)Nervous system disorders 29 (8.8) 36 (11.0)Psychiatric disorders 10 (3.0) 4 (1.2)Respiratory, thoracic andmediastinal disorders6 (1.8) 13 (4.0)Skin and subcutaneous tissuedisorders21 (6.3) 24 (7.3)Vascular disorders 7 (2.1) 4 (1.2)
  10. 10. 10ESTABLISH 2 Post-Baseline Substantially AbnormalHematology ValuesTedizolid, (%)n = 331Linezolid, (%)n =327Hemoglobin 292 287Below LLN 147 (50.3) 148 (51.6)Substantially abnormal 4 (1.4) 2 (0.7)White blood cells 272 258Below LLN 16 (5.9) 20 (7.8)Substantially abnormal 3 (1.1) 5 (1.9)Platelets 275 269Below LLN 37 (13.5) 35 (13.0)Substantially abnormal 9 (3.3) 5 (1.9)
  11. 11. 11Differences Between ESTABLISH 1 and 2ESTABLISH 2 ESTABLISH 1DosingIV to oral(minimum 1st day’s dosing IV)OralDemographics US 47%, x-US 53% US 80%, x-US 20%MRSA, % 27.1 42.6PrimaryEndpoint*> 20% reduction in lesionarea @ 48 to 72 hrsCessation of lesion spread,absence of fever @ 48 to 72 hrs*ESTABLISH 2 SPA amended under agreement with FDA to reflect expected new primary endpoint. Both endpointsprospectively captured as sensitivity analyses in respective studies. Integrated summary of efficacy will reflect theESTABLISH 2 primary endpoint under the amended SPAs
  12. 12. 12ESTABLISH Program ComparisonEndpoint StudyTedizolid6 daystreatment, %Linezolid10 daystreatment, %TreatmentDifference(95% CI), %≥20% decrease frombaseline in lesion area at48-72 hoursESTABLISH 2ESTABLISH 185.278.082.676.12.6 (-3.0 to 8.2)1.9 (-4.5 to 8.3)Sustained clinicalresponse at end oftherapyESTABLISH 2ESTABLISH 187.087.088.087.8-1.0 (-6.1 to 4.1)-0.8 (-5.8 to 4.4)Investigators assessmentof clinical response at 7-14 days after end oftherapyESTABLISH 2ESTABLISH 188.085.587.786.00.3 (-4.8 to 5.3)-0.5 (-5.8 to 4.9)Cessation of lesionspread and absence offever at 48-72 hrsESTABLISH 2ESTABLISH 185.879.581.479.44.4 (-1.2 to 10.1)0.1 (-6.1 to 6.2)
  13. 13. 13ESTABLISH Program Safety ComparisonSafety Analysis Set Study Tedizolid % Linezolid %Any TreatmentEmergent AdverseEvent (TEAE)ESTABLISH 2 45.3 43.7ESTABLISH 1 40.8 43.3Any Drug RelatedTEAEESTABLISH 2 20.5 24.8ESTABLISH 1 24.2 31.0GastrointestinalDisordersESTABLISH 2 16.0 20.5ESTABLISH 1 16.3 25.4
  14. 14. 14Summary• All primary and secondary efficacy endpoints were met for FDA and EMA• Safety profile indicated that tedizolid was safe and well tolerated• Results are consistent with those from ESTABLISH 1 and support filings forglobal regulatory approval• Combined results of all clinical studies support tedizolid differentiation:– Safe, well tolerated, fast acting drug for resistant gram positive infections– Convenient once daily IV or oral administration over short course of therapy– Fewer drug-drug interactions– Active against key linezolid resistant strains
  15. 15. 15*Efficacy performance ratings among those aware of brandTedizolid ATU Study, Wave 1 – USA Report, conducted by CMI on behalf of Trius, November 2012, N=505Strong Response to Tedizolid Efficacy, Dosing andAdministration*Tedizolid, 65%Tedizolid, 52%Zyvox, 62%Zyvox, 42%Cubicin, 54%Cubicin, 37%Vancomycin, 25%Vancomycin, 27%Offers simple dosing andadministrationHas a lower potential forresistance developmentKeyDriversofMarketShareKeyDriversofPreferenceTedizolid, 45%Tedizolid, 42%Zyvox, 45%Zyvox, 38%Cubicin, 42%Cubicin, 37%Vancomycin, 30%Vancomycin, 30%Has superior efficacy vs.other productsIs effective for all patienttypes
  16. 16. 16Strong Response to Tedizolid Safety & TolerabilityKeyDriversofMarketShareTedizolid, 48%Tedizolid, 53%Tedizolid, 59%Zyvox, 27%Zyvox, 45%Zyvox, 31%Cubicin, 48%Cubicin, 42%Cubicin, 44%Vancomycin, 39%Vanco., 14%Vancomycin, 25%Has a low frequency ofDDI (drug-druginteraction)Does not cause renaland hepatic impairmentHas a low frequency ofsafety/adverse events*Efficacy performance ratings among those aware of brandTedizolid ATU Study, Wave 1 – USA Report, conducted by CMI on behalf of Trius, November 2012, N=505
  17. 17. 1780%69% 74% 72% 76%92%83%19%31% 25% 27% 23%7%17%High Interest (8-10)Neutral (4-7)Low Interest (1-3)Tedizolid ATU Study, Wave 1 – USA Report, conducted by CMI on behalf of Trius, November 2012, N=505Base: Total respondentsQ8.1 How interesting is tedizolid to you for suspected or confirmed MRSA ABSSSI patients overall? Use a 1 to 10 scale where “1” means “Not at all Interesting”and “10” means “Very Interesting,” to indicate your level of interest.Interest in Tedizolid, by Specialty(0 = Not Interested, 10 = Very Interested)Physician Interest in Tedizolid Strong Across SpecialtiesTotal(N = 505)Critical Care,Pulmonologist(n = 120)Internist(n = 137)GeneralSurgeon(n = 86)Hospitalist(n = 175)InfectiousDiseaseSpecialist(n = 101)Infusion ClinicSpecialist(n = 75)
  18. 18. 18Upcoming Milestones• Late breaker presentations at ECCMID conference (submitted for April)• Detailed data presentations at ICAAC conference (September)• Advance EU partnership discussions• NDA Filing (H2 2013)• Implement pre-commercial activities for potential U.S. launch (H2 2013)• Initiation of Phase 3 ventilated nosocomial pneumonia study (H2 2013)• EMA Filing (H1 2014)• Potential PDUFA date for ABSSSI (mid 2014)
  1. A particular slide catching your eye?

    Clipping is a handy way to collect important slides you want to go back to later.

×